Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0697

2. Registrant Information.

Registrant Reference Number: 2017CP008

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

27-JAN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

15-NOV-16

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-107

Product Name: Cylence Pour On

• Active Ingredient(s)
  • CYFLUTHRIN
    • Guarantee/concentration 1 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

an unknown amount was applied topically to a bovine

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cow / Vache

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.7

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Respiratory System
  • Symptom - Other
  • Specify - unspecified respiratory clinical signs

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 15Nov2016, the bovine, at nine months of age, were shipped to a feedyard and upon arrival were administered a bovine combination vaccine, a bovine clostridial vaccine, a bovine Haemophilus somnus vaccine, an injectable bovine vitamin supplement via unknown routes, an unspecified dose of Cydectin 1% Injectable (Moxidectin) via an unknown route, an unspecified amount of CyLence Pour-On Insecticide (Cyfluthrin) topically, and received an identification tag placed in one pinna. Fifteen of the bovine developed unspecified respiratory clinical signs. One of the 15 symptomatic bovine died. died. It was unknown if a veterinarian was consulted or if a necropsy examination was performed.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

no post mortem was done